Serum albumin, the most abundant protein in plasma, contributes to the maintenance of osmotic pressure and binds to and transports nutrients and metabolites. Preparations containing the above-mentioned albumin have been used in the treatment of hypoalbuminemia and hemorrhagic shock due to a loss of albumin or in the ability to synthesize albumin.
Generally, albumin preparations are prepared from plasma via several purification stages. During detailed studies on contaminants of albumin preparations, the present inventors found that albumin preparations contain a significantly large amount of aluminum.
In recent years, attention has been directed to the correlation between aluminum and various diseases. For example, it is believed that bone diseases accompanied by serious pain, which are observed frequently in patients experiencing hemodialysis or prolonged instillation, are caused by aluminum contained in solutions employed in those treatments.
It is considered, furthermore, that dialysis dementia, bone diseases and hypochromic anemia observed in patients undergoing hemodialysis for treating chronic renal insufficiency are caused by the accumulation of aluminum in serum.
In addition, the correlation between aluminum in brain tissue and Alzheimer's disease (senile dementia) has attracted attention.
In view of those observations, attempts have been made world-wide to control the aluminum content of medical preparations.
There are a variety of hard glasses (borosilicate glass; falling within Class I in the Glass Classification of USP) and soft glasses (soda-lime glass, falling within Class II in the Glass Classification of USP) having a dealkalized surface which serve as materials of containers for injectable materials. Soft glass has a low melting point, can be easily molded and is less expensive than hard glass. These materials differ from each other in other physical properties, including chemical resistance. Thus different glasses have been used depending on the drugs to be contained. Hard glass containers are usable for preserving acidic, neutral or alkaline drug-containing solutions. On the other hand, soft glass containers are usable for preserving acidic and neutral drug-containing solutions, whereas the suitability for storing alkaline drug-containing solutions must be confirmed.
Hard glass containers which are excellent in chemical resistance have been employed conventionally and uniformly for preserving albumin preparations.